FDA 510(k) Applications Submitted by GenBio

FDA 510(k) Number Submission Date Device Name Applicant
K010301 02/01/2001 IMMUNOWELL EA (D) IGG TEST GenBio
K963054 08/06/1996 IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) GenBio
K963055 08/06/1996 IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 GenBio
K953682 08/07/1995 IMMUNO DOT BORRELIA DOT BLOT G TEST GenBio
K953683 08/07/1995 MMUNO DOT BORRELIA DOT BLOT M TEST GenBio
K973939 10/15/1997 IMMUNOWELL VCA IGM TEST GenBio
K973940 10/15/1997 IMMUNOWELL EBV VCA IGG TEST GenBio
K973941 10/15/1997 IMMUNOWELL EBNA IGG TEST GenBio
K974226 11/12/1997 IMMUNODOT MONO-G TEST GenBio
K974244 11/12/1997 IMMUNODOT MONO-M TEST GenBio


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